Scand J Rheumatology 11: 39-40, 1982

XEROSTOMIA IN SJOGREN’S SYNDROME TREATED WITH SALI-SYNT@

A Double-blind Cross-otw T r i d

K. Kaarela’ and 0. Mutru2

From the ‘Rheumatism Founduiion Hospiiul, Heinolu and the ‘Depurtmrnt ($Medicine, Unitvrsity of Kuopio, Finland

ABSTRACT. In a double-blind cross-over trial, a new synthetic saliva Sali-Synt@ was compared with placebo for the treatment of xerostomia in Sjogren’s syndrome. Sali- Synt@ may soothe the pain in the mouth and reduces sleep disturbances better than placebo, but no statistically sig- nificant differences were found. Seven patients of 12 pre- ferred Sali-Synt@ to placebo in helping xerostomia.

Sjogren’s syndrome is a chronic auto-immune dis- ease in which chronic inflammation of the exocrine glands resuls in a dryness of mouth and eyes. The eye symptoms are customarily treated with artifical tears, but xerostomia is particularly resistant to treatment.

In this study a new synthetic saliva (Sali-Synt@) was compared with placebo.

MATERIALS AND METHODS Twelve female patients with a definite ( I ) Sjogren’s syn- drome used synthetic saliva and placebo for 2 weeks each in a double-blind and cross-over study. The 7 patients from Kuopio showed a typical histology in biopsies of the salivary glands in the lip, diminished excretion of the parotic glands at scintigraphy and also diminished lacrimal excretion. All the 5 patients from Heinola had keratocon- junctivitis sicca and marked objective xerostomia; 3 of them had erosive rheumatoid arthritis and 2 had a typical histology of the salivary glands. The age of the patients varied from 38 to 74 years (mean age 52 years). The duration of xerostomia before the study ranged from 5 months to 12 years (average 6 years).

(1 Remeda Pharmaceutical Co., Finland) Kalium chloride Natr. chlorid. Magnesium chloride 6 H,O

Calcium chloride 6 H20

Natr. fluoride

The formula of Sali-Synt’ is as follows:

(respond. MgCI, 6 mg/lOO ml)

(respond. CaCI, 17 mg/100 ml)

(respond. F 2 ppm)

mg 63 87

13

33

0.442

Kalium phosph. 3 H,O (respond. K,HPO, 80 mgl100 ml) 105

Kalium dihydrogenphosph. 33 Kalium thiocyanate 10 Addenda et corrig. q.s. Aq. purif. ad 100

Placebo was water but with the same taste as Sali-Synt@. Both liquids were used in spray form (100 ml bottles with mechanical pumps), and the patients sprayed their mouths 2-3 times whenever felt necessary.

The following subjective symptoms were registered be- fore treatment and on the seventh and fourteenth day of treatment with both preparations: pain in the oral mucous membranes, a general bad taste in the mouth, problems with mastication, in sleeping, and in speaking, as well as interference with the use of false teeth.

The patient’s own estimation of dryness of mouth was registered too. The scale used was: 0 = no symptoms, 1 = mild symptoms, and 2 = severe symptoms.

Mean values and standard deviations for symptom val- ues were calculated.

RESULTS

Results of the treatment of the subjective symptoms are shown in Table I . Speech was aided with the use of Sali-Synt@, but clearly more so with placebo. The degree of pain in xerostomia was distinctly reduced by Sali-Synt@, but there were no changes with placebo on the seventh day and only moderate ones on the fourteenth day. Xerostomia disturbed sleep less particularly on the fourteenth day of Sali-Synta use, but placebo gave less satisfactory results. No statistically significant differences were found when the results of treatment with Sali-Synt@ vis-a-vis placebo were compared. Nine patients had false teeth, but no change was noticed in their per- formance during the study.

The use of both preparations did not differ significantly either on the seventh or on the four- teenth day, e.g. on the fourteenth day the patients

Scand J Rheidmnrology 11

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Table I . Metrn degree o f serioustiess o j sytnptorns t$er o n e crnd 2 uveX.7 of plirceho trnd .Strli-Synt@ treutment

Symptom scores from 0 to 2 (meankSE, n=12)

After Sali-Synte treatment After placebo treatment The symptoms of Before xerostomia treatment 7 days 14 days 7 days 14 days

In eating 1.0k0.2 0.8k0.2 0.8k0.2 0.nk0.2 0.nk0.2 In speech 1.4k0.2 1.2k0.2 1.1 k0.2 I .0k0.2 0.9k0.2 In sleep 0.7k0.2 0.5k0.2 0.3k0.1 0.6k0.2 0.5k0.2 Painful oral mucosa 0.8k0.2 0.3k0.1 0.4k0.1 0.8k0.2 0.5+0.2 Bad taste 0.7k0.3 0.4k0.1 0.55-0.2 0.6k0.2 0.5k0.2 Subjective opinion of the dryness of the mouth 1.3k0.2 0.9k0.2 0.9k0.2 1.0k0.2 0.9k0.2

used Sali-Synt@ 11.9k4.0 times a day and placebo 12.5k3.7 times a day.

When asked after the study, 7 patients preferred Sali-Synt@ to placebo, one preferred placebo, and the other 4 found them identical in helping xero- stomia (p=O.Ol in Fisher’s exact probability test).

Five patients continued with the treatment with Sali-Synt@ for 4 months in an open study. None of the registered symptoms returned to its original level. The best effect was obtained against oral pain.

Regarding the objective condition of mucous membranes, tongue and gums, no significant changes were found during the study.

DISCUSSION

pain in the oral mucous membranes and reduce sleep disturbances more effectively than plain wa- ter. Because of its higher viscosity it has apparently a longer effect than water.

Speech was also helped, though better with wa- ter. Obviously the smaller particles of watery mois- ture reached the vocal cords better. N o side effects were found throughout the study.

This study indicated that Sali-SynP seems to be an acceptable treatment for severe xerostomia, especially if ample fluid is not available or is not recommended.

REFERENCE 1. Shearn, M. A,: Sjogren’s Syndrome, p. 11. W. B.

Saunders Company, Philadelphia, 1971.

It is hardly possible to increase salivary secretion Submitledfiw publication Fehruury 6 , 1981 .~

by means of any kind of medication in serious Sjo- gren’s syndrome. Such patients need extra moisture K. Kaarela

Rheumatism Foundation Hosoital in the mouth. SF-18120 Heinola

This study shows that Sali-Synt@ can soothe the Finland

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